Fluorouracil Cream
FDA Recall NDC 51672-4118
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fluorouracil (NDC 51672-4118). A significant event, classified as Class II, was initiated on Nov 21, 2012 by Taro Pharmaceuticals U.s.a., Inc.. The reported reason for this action was: "Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Nov 21, 2012
Dec 12, 2012
39,982 Tubes
Recall Profile & Regulatory Data
Event ID
63685
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Apr 11, 2017
Product Description
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Batch or Lot Expiration Information
Lot# s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.
Affected Packages Involved in this Recall
51672-4118-5Product
51672-4118-2Product
51672-4118-6Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
